Services- PRO Strategy Planning

At Bottomley Consulting Group (BCG), we support pharmaceutical and biotech companies in developing integrated, regulatory-aligned strategies for Clinical Outcome Assessment (COA)—with a particular focus on Patient-Reported Outcomes (PROs) and related tools across the trial continuum.

With decades of hands-on leadership in oncology, regulatory science, and QOL research, Dr. Andrew Bottomley brings a depth of insight into how COAs can be optimally designed, validated, and positioned to support both clinical development and market access.

💡 Why a COA Strategy Matters

In today’s evidence-driven environment, COAs are no longer optional—they are pivotal in understanding treatment benefit from the patient’s perspective. Regulatory bodies like the FDA, EMA, and HTA agencies increasingly require or recommend the inclusion of COAs to support claims of clinical benefit, tolerability, and health-related quality of life.

Without a clearly articulated COA strategy, companies risk:

Suboptimal data that fails to meet regulatory expectations

Inconsistent or invalidated endpoints

Missed opportunities for label differentiation and payer engagement

🧠 What BCG Offers

BCG’s strategic consulting services are designed to guide you through every stage of COA integration, including:

COA Planning Workshops: Tailored sessions to map COA strategy to your indication, trial design, and regulatory path

Instrument Selection & Gap Analysis: Expert guidance on choosing the right PRO, ObsRO, or ClinRO tools (e.g., EORTC, PROMIS, EQ-5D)

Validation and Psychometric Support: Ensuring your chosen endpoints meet evidentiary standards for reliability and validity

Regulatory and HTA Engagement: Preparation of documentation, briefing books, and meeting support for FDA/EMA/HTA discussions

Protocol & SAP Review: Embedding COAs into trials effectively without overburdening sites or patients

🚀 The BCG’s strategic input has helped multiple sponsors achieve:

Improved patient engagement and retention

Increased data quality and endpoint interpretability

Faster, more confident interactions with regulators

Clearer demonstration of value for reimbursement discussions

Our philosophy is simple: make the patient experience measurable, credible, and central to your trial strategy.

📞 Let’s Talk

Whether you’re preparing an early-phase trial or heading into pivotal studies, Bottomley Consulting Group can help craft a COA strategy that adds value across development, approval, and access.

Reach out to explore how BCG can partner with your team to build better, patient-centered evidence.